Diabetes foot
Conditions
Interventions
Placebo group:tibial cortex transverse transport combined with placebo
Probiotic group:tibial cortex transverse transport combined with probiotic
Sponsors
Guangdong Second People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. Wagner grading of foot lesions 2,3 or 4 on lower limb not healing for at least 4 weeks. 3.Patency of the popliteal artery >50%, diagnosed through doppler ultrasound examination. 4. informed and consented.
Exclusion criteria
Exclusion criteria: 1. Mental illness that did not allow the patients to cooperate with the treatment. 2. Diagnosis (by an endocrinologist) of other uncontrollable serious complications of diabetes. 3. Inability to tolerate anaesthesia due to cardiovascular complications or renal failure. 4. Presence of non-diabetic ulcers. 5. Calf skin condition not meeting the surgical requirements. 6. Presence of active Charcot foot. 7. A history of cerebral infarction, myocardial infarction, heart failure,cancer, or renal failure in the past 3 months. 8. Treatment with corticosteroids, immunosuppressive drugs, and/or chemotherapy. 9.Chronic gastrointestinal disease (except irritable bowel syndrome) 10. Systemic antibiotics within 6 weeks before inclusion 11.Use of probiotics within 3 months before inclusion 12.Regular intake of insulin or insulin analogs, antibiotics or probiotics, antacids, H2-receptor blockers, proton pump inhibitors, loperamide, cholestryramine, ?3-unsaturated fatty acid supplements, fibrates, corticosteroids or sex steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing;Vascular examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood sugar;HbA1c;Insulin;C-peptide;Total cholesterol;Highdensity lipoprotein cholesterol;Low-density lipoprotein cholesterol;Triglycerides;Alanine aminotransferase;Aspartate aminotra;SF-36;EQ-5D;DFS-SF;Intestinal flora; | — |
Countries
China
Contacts
Public ContactQi Yong
Outcome results
None listed